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Re: DewDiligence post# 196009

Friday, 10/16/2015 5:01:14 AM

Friday, October 16, 2015 5:01:14 AM

Post# of 252525
PTCT:

Will the EMA revoke Translarna’s conditional approval? (Did anyone ask about this on today’s CC?)


The question came up and they didn't directly answer. They vaguely replied about EMA looking to see benefit and implicit in the reply was this study does that. It comes up in the 50-56 minute mark (didn't catch the name of the analyst).

They were asking about other prespecified analysis and they did have one for < 350 though they did not give details. The same analyst who asked about EMA asked what I did (on twitter) about the other 129 and those < 300 as well as those > 400. They said they were basically the same though didn't give numeric details.

The summary of the call is basically. < 300 too progressed to show benefit, > 400 to stable to show benefit.

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